A Pilot Unrestricted Payment Program for Early-stage Cancer Patients: the PAYMENT Trial

Not Applicable

Not yet recruiting

• Conditions: Malignant Solid Neoplasm

• Registration Number: NCT06771739
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary

This clinical trial studies whether an unrestricted cash payment program can be used to improve financial and clinical outcomes in early-stage cancer patients with financial concerns. A cancer diagnosis can have poor financial outcomes, and the cost of cancer treatment can lead to high medical debt and financial hardships for the patient and family. Financial hardship during cancer treatment is associated with adverse outcomes including poorer quality of life, lower treatment compliance, more aggressive use of hospital-based care, and worse survival. Newly diagnosed cancer patients with financial concerns may avoid treatment entirely so that they can continue to work and maintain income, provide for their families, or pay rent. An unrestricted cash payment program provides patients with a preloaded cash card once monthly. The patients can choose what to use the card to pay for and may include items like food, rent, or utilities. This provides a period of guaranteed income for the patients and may prevent them from falling into poverty and improve financial and clinical outcomes.

Detailed Description

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive a $1000 preloaded cash card once monthly for 3 months.

ARM B: Patients receive a $100 preloaded cash card once monthly for 3 months.

After completion of study intervention, patients are followed up 3 months and 6 months post randomization.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-08
• Study First Posted: 2025-01-13
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-23
• Study Start: 2025-06-21
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age >= 18
• Ability to understand English
• Ability to understand and willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants
• Within 90 days of a non-metastatic or early-stage solid tumor receiving or rescheduled to receive treatment in the neoadjuvant, adjuvant or definitive setting for curative intent. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
• Current cancer patient at PeaceHealth (Southwest Medical Center or St. Joes)
• Not current Medicaid enrollee
• Not enrolled in hospice
• Screens positive for financial fragility

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Participant enrollment	Up to 1 year	Feasibility will be measured by participant enrollment (percent enrolled versus \[vs.\] approached). The study will be considered feasible to implement if 60% or more of approached patients enroll.
Time to accrue 20 patients	Up to 1 year	Feasibility will be measured by the time in months to accrue 20 patients. The study will be considered feasible if accrual is reached by 6 months.
Dropout rate	Up to 1 year	Feasibility will be measured by dropout during study period. The study will be considered feasible to implement if less than 20% of patients drop out. Will be able to estimate a drop-out rate of 20% to within a 95% confidence interval of +/- 18%.
Survey completion rate	Up to 1 year	Feasibility will be measure by rates of survey completion. The study will be considered feasible to implement if survey completion is 90% or greater.

Secondary Outcome Measures

Name	Time	Method
Financial hardship	Baseline, 3 and 6- months post randomization	Will assess whether patient self-reports one or more of the following: new debt (relative to baseline), income decline of 20% or more, loans from family/friends to pay for cancer treatment, selling/refinancing primary home, \>= 2 months missed rent or mortgage payments, evictions. May adjust either the methods for assessing financial hardship (e.g. using credit reports rather than surveys) or the endpoint itself based on observed survey completion rate and incidence of each endpoint.
Unplanned emergency department (ED)/hospital admissions	Baseline, 3 and 6- months post randomization	All instances of ED visits and hospital stays (including reason for visit) will be abstracted from patients' medical records. The study team will categorize visits as anticipated (for chemotherapy or planned procedure) vs. unanticipated (complication or treatment side effect).
Food and housing insecurity	Baseline, 3 and 6- months post randomization	Will be assessed using items 1 through 4 of the 10-item Health-Related Social Needs Screening Tool from Centers for Medicare and Medicaid Services.
Treatment nonadherence	Baseline, 3 and 6- months post randomization	Will assess whether patient self reports they did or did not skip medication doses or refuse/decline recommended therapy due to cost concerns. Evidence of treatment completion vs. missed treatments/appointments using data from electronic medical record captured by research assistant.
Quality of life	Baseline, 3 and 6- months post randomization	Will be assessed using the composite score from the European Quality of Life Five Dimension Index (scored 0-100). A 6-point score change is considered clinically meaningful in United States cancer populations.

Trial Locations

Locations (2)

PeaceHealth Saint Joseph Medical Center; 🇺🇸 Bellingham, Washington, United States

PeaceHealth Southwest Medical Center; 🇺🇸 Vancouver, Washington, United States